A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Summary

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Timeline

Start

2008-07-17

Primary completion

2012-03-09

Completion

2023-11-08

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo / Ocrelizumab 600 mg vs Ocrelizumab 600 mg / Ocrelizumab 600 mg; p <0.0001; Van Elteren Test (stratified) NCT00676715 ↗

registry analysis (unspecified test); Placebo / Ocrelizumab 600 mg vs Ocrelizumab 1000 mg/ Ocrelizumab 600 mg; p <0.0001; Van Elteren Test (stratified) NCT00676715 ↗

Publications

• Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Interferon beta-1a	Protein / enzyme biologic	30 ug	Intramuscular
Subject	Ocrelizumab	Monoclonal antibody	600 mg	Intravenous
Subject	Ocrelizumab	Monoclonal antibody	1000 mg	Intravenous

Indications